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Abstract:

Device and method for rapid extraction of body tissue from an enclosed
body cavity. Hollow entry cannula with optional core element provides
entry into body tissue space such as bone marrow. Aspiration cannula is
inserted through cannula into body tissue and is manipulated to advance
directionally through body cavity. Optional stylet within aspiration
cannula aids in advancing aspiration cannula through body tissue and is
removed to facilitate extraction of body tissue through the aspiration
cannula. Inlet openings near distal tip of aspiration cannula allow
tissue aspiration, with negative pressure source at proximal end of
aspiration cannula providing controlled negative pressure. Aspiration
cannula may be withdrawn and its path adjusted for multiple entries
through the same entry point, following different paths through tissue
space for subsequent aspiration of more tissue.

Claims:

1. A method for aspirating and introducing body tissue, comprising:
aspirating a portion of body tissue into an aspiration cannula having a
flexible length, wherein the cannula is introduced into the body tissue
through an entry port defined along a body cavity containing the body
tissue; processing the aspirated body tissue to enrich at least one
population of cells contained therewithin; introducing the enriched at
least one population of cells into a tissue region of interest.

Description:

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of U.S. application Ser. No.
11/675,031 filed Feb. 14, 2007 which is a continuation of U.S.
application Ser. No. 10/454,846 filed Jun. 4, 2003, now U.S. Pat. No.
7,462,181, which claims priority to U.S. Provisional Application No.
60/384,998 filed Jun. 4, 2002, each of which is incorporated herein by
reference in its entirety.

BACKGROUND

[0002] 1. Field

[0003] Invention relates generally to the field of medicine and more
specifically to a device and method for rapid extraction of tissue from
an enclosed body cavity.

[0004] 2. Related Art

[0005] Bone Marrow is a rich source of pluripotent hematopoietic stem
cells from which red blood cells, white blood cells, and platelets are
formed. Bone marrow also contains additional populations of cells which
have the potential to regenerate other tissues.

[0006] Since the early 1970's bone marrow and hematopoietic stem cell
transplantation has been used to treat patients with a wide variety of
disorders, including but not limited to cancer, genetic and autoimmune
diseases. Currently over 400,000 transplants for a variety of indications
are performed worldwide each year.

[0007] In autologous transplants, the patient has their own bone marrow
collected prior to receiving high dose chemotherapy. Following high dose,
myeloablative chemotherapy (which kills the majority of the patients
marrow stem cells) the stored autologous marrow (or hematopoietic stem
cells purified or enriched from the marrow) is infused, and serves to
`rescue` the patient's hematolymphoid system.

[0008] In allogeneic transplants bone marrow, or other sources of
hematopoietic stem cells derived from a full or partially human leukocyte
antigen (HLA) matched sibling, parent or unrelated donor is infused into
the recipient patient and following engraftment, serves to reconstitute
the recipients hematopoietic system with cells derived from the donor.

[0009] Following myeloablative or non-myeloablative conditioning of a
patient with chemotherapy and/or radiation therapy, the marrow is
regenerated through the administration and engraftment of hematopoietic
stem cells contained in the donor bone marrow.

[0012] Stem cells utilized in transplantation are primarily collected in
one of two ways. First, by directly accessing the bone marrow (bone
marrow harvest), in which marrow is removed from the patient, usually by
multiple aspirations of marrow from the posterior ileac crest, in a bone
marrow harvest procedure performed in the operating room. A second
collection method is performed by removal of mononuclear cells from the
donor's peripheral blood (which contains a fraction of hematopoietic stem
cells as well as other populations of cells including high numbers of
T-cells. In this procedure peripheral blood stem cells are collected by
apheresis following donor treatment with either chemotherapy (usually
cyclophosphamide) or with the cytokine Granulocyte Colony Stimulating
Factor (GCSF). Treatment with cyclophosphamide or GCSF functions to
mobilize and increase the numbers of hematopoietic stem cells circulating
in the blood.

[0013] Traditional bone marrow harvest procedures have several
shortcomings: [0014] To perform a harvest of 500-1000 milliliters of
marrow, multiple separate entries into the marrow cavity are required to
in order to remove a sufficient amount of bone marrow. A bone marrow
aspiration needle (sharp metal trocar) is placed through the soft tissue,
through the outer cortex of the ileac crest and into the marrow space.
The aspiration needle enters less than 2 cm into the marrow cavity.
Negative pressure is applied through the hollow harvest needle (usually
by the operator pulling on an attached syringe into which 5-10 ml of
marrow is aspirated). The needle and syringe are then removed and after
removing the collected marrow, the aspiration needle accesses a separate
location on the ileac bone for another aspiration. This is performed
multiple times (on the order of 100-200 separate entries for an average
patient) in order to remove a sufficient volume of bone marrow required
for transplantation. Each puncture and entry into the marrow cavity
accesses only a limited area of the marrow space, and the majority of
practitioners only remove 5-10 milliliters of marrow with each marrow
penetration. Pulling more marrow from a single marrow entry site
otherwise results in a collected sample highly diluted by peripheral
blood. [0015] General anesthesia--The bone marrow harvest procedure
requires general anesthesia. General anesthesia is required because the
ileac crest is penetrated 100-300 times with a sharp bone marrow trocar.
Local anesthesia is generally not possible given the large surface area
and number of bone punctures required. [0016] Recovery Time--The donor
can take some time recovering from general anesthesia, and frequently
suffers from days of sore throat, a result of the endotracheal intubation
tube placed in the operating room. [0017] Time consuming for
patient--Pre-operative preparation, the harvest procedure, recovery from
anesthesia, and an overnight observation stay in the hospital following
the procedure is an imposition on the donor. [0018] Time Consuming for
the physician: In addition to general operating room staff, the
traditional bone marrow harvest procedure requires two transplant
physicians (each physician aspirating marrow from the left or right side
of the ileac crest) and. Who spend approximately one hour each to perform
the procedure. [0019] Pain--Many donors experience significant pain at
the site of the multiple aspirations (bone punctures) which persists for
days to weeks. [0020] Complications--Traditional bone marrow aspiration
incurs a significant degree of contamination with peripheral blood.
Peripheral blood contains high numbers of mature T-cells (unlike pure
bone marrow). T-cells contribute to the clinical phenomenon termed Graft
vs. Host Disease (GVHD), in both acute and chronic forms following
transplant in which donor T-cells present in the transplant graft react
against the recipient (host) tissues. GVHD incurs a high degree of
morbidity and mortality in allogeneic transplants recipients. [0021]
Expensive--Cost of the procedure $10-15K, which includes costs for
operating room time, anesthesia supplies and professional fees, and
post-operative care and recovery.

[0022] Peripheral Blood Stem Cell Collection also has several
shortcomings: [0023] Slow and time consuming--Requires the donor to
first undergo 7-10 or more days of daily subcutaneous injections with
high doses of the cytokine GCSF prior to the harvest. These daily
injections can be uncomfortable and painful. Peripheral blood stem cells
can not be obtained without this 7+ day lead time. [0024] Expense--Each
day of apheresis costs approximately $3000 (including but not limited to
the cost of the apheresis machine, nursing, disposable supplies and
product processing) and the patient often has to come back on multiple
days in order to obtain an adequate number of stem cells. Costs for the
GCSF drug alone approximate $6,000-10,000 depending upon the weight of
the patient (usually doses as 10 micrograms/kilogram/day). [0025]
Complications--Given the multiple days required to collect adequate
numbers of hematopoietic stem cells, individual bags of peripheral blood
product must processed and frozen separately. These bags are then thawed,
and given back to the recipient patient at the time of transplant. The
volume, and chemicals contained in the product freezing media can cause
some mild side effects at the time of infusion.

[0026] Accordingly, there is a need for a minimally invasive, less
expensive, time-efficient bone marrow harvest procedure with minimal
complications which does not require general anesthesia, offers fast
recovery time, and does not cause significant pain to the bone marrow
donor.

SUMMARY

[0027] Device and method for rapid extraction of body tissue from an
enclosed body cavity. Device comprises a hollow introduction cannula
containing a trocar. Entry cannula and core element penetrate body tissue
such as the marrow space contained within the ileac or other bone.
Aspiration cannula is inserted through entry cannula into body tissue and
advances through the body cavity. Within the aspiration cannula there may
be a stylet (aspiration stylet), which can aid in the advance of the
cannula through cavity and can be removed to facilitate extraction of
body tissue through the aspiration cannula. Aspiration cannula has inlet
openings near the distal tip through which tissue is aspirated. At the
proximal end of aspiration cannula a negative pressure (suction) source
provides controlled negative pressure enabling tissue to be aspirated
through aspiration cannula into a collection reservoir. Aspiration
cannula may be withdrawn and adjusted for multiple entries through the
same tissue entry point, following different paths through tissue space
for subsequent aspiration of more tissue.

BRIEF DESCRIPTION OF DRAWINGS

[0028] FIG. 1 is a diagram illustrating a device for rapid aspiration and
collection of body tissue from within an enclosed body space, according
to one embodiment of the present invention.

[0029]FIG. 2 illustrates entry cannula 101 with core element 104,
according to one embodiment of the present invention.

[0030] FIG. 3 illustrates aspiration cannula, according to an embodiment
of the present invention.

[0031] FIG. 4a shows aspiration cannula with one or more steering wires,
according to an embodiment of the present invention.

[0032] FIG. 4b shows perforated wall and cross-section of aspiration
cannula, according to an embodiment of the present invention.

[0033] FIG. 4c shows universal joint of aspiration cannula, according to
an embodiment of the present invention.

[0034] FIG. 4d shows squash plate of aspiration cannula, according to an
embodiment of the present invention.

[0035] FIG. 4e shows preset degree of curvature of aspiration cannula,
according to an embodiment of the present invention.

[0036]FIG. 5 illustrates a groove cup, according to an embodiment of the
present invention.

[0037] FIG. 6a illustrates a distal tip, according to an embodiment of the
present invention.

[0038]FIG. 6b illustrates a sharp tip, a rotating drill tip and a
sonication device, according to an embodiment of the present invention.

[0039] FIG. 6c illustrates a sonication device and an ultrasound
transducer, according to an embodiment of the present invention.

[0040] FIG. 6d illustrates an example of a distal tip modified to have a
rounded blunt tip, according to an embodiment of the present invention.

[0041] FIG. 7 illustrates inlet openings near the distal tip of aspiration
cannula, according to an embodiment of the present invention.

[0042] FIG. 8 illustrates additional ports of aspiration cannula,
according to an embodiment of the present invention.

[0043]FIG. 9 illustrates optional reservoir for materials or liquids for
administration, and optional electric motor, according to an embodiment
of the present invention.

[0044]FIG. 10a illustrates how the device for rapid aspiration and
collection of body tissue from within an enclosed body space enables a
single operator to harvest marrow through one bone entry point, in
accordance with an embodiment of the present invention.

[0046] FIG. 11 illustrates a method for rapid aspiration and collection of
body tissue from within an enclosed body space, according to an
embodiment of the present invention.

[0047] FIG. 12 shows entry site on one side of the body with multiple
aspiration paths, according to an embodiment of the present invention.

DETAILED DESCRIPTION

Overview

[0048] An apparatus is provided to aspirate bone marrow and/or tissue
rapidly and for large volumes of bone marrow from the ileac, femur, or
other marrow containing bone marrow cavities. The apparatus includes a
lumen adapted to receive an elongated aspiration cannula. Following entry
through the bone wall, the aspiration cannula may be controlled to move
in a non-linear fashion within the marrow cavity so that it can access a
majority of bone marrow space through a single point of entry. Suction
may be applied to the aspiration cannula to harvest the bone marrow or
other aspiratable substances. If it is determined that a threshold amount
of aspiratable substance has not been obtained, the aspiration cannula
may be adjusted to enable further harvesting from the same bone wall
entry or from an alternative bone wall entry.

[0049] Device and method for rapid, minimally invasive, aspiration and
collection of body tissue from within an enclosed body space, as
described herein, provide following advantages over the existing harvest
systems: [0050] Efficacy--traditional extraction accesses only a small
volume of marrow with each needle insertion and negative pressure draws
blood from surrounding capillaries and dilutes the extract. Invention
described herein moves to directly contact more of the marrow space and
aspirates a more concentrated, less diluted extract. The extracted bone
marrow is more concentrated in stem cells because the device penetrates
the pelvic cavity more broadly and thus the extracted material is less
diluted with blood drawn into the void created by the extraction. The
decreased numbers of contaminating T-cells will likely lead to less Graft
vs. Host Disease (GVHD) in allogeneic bone marrow recipients. Less total
volume of bone marrow will need to be removed (as it is more
concentrated). [0051] Efficiency--the harvest performed with the
invention described herein proceeds faster than conventional trocar
harvest because only one access point into the marrow cavity is needed on
each side of the body and less total volume of material is extracted (as
it is more concentrated). One possible marrow access point is the easily
accessible anterior ileac crest access site, which is easier to find and
access on a broad array of patients (from thin to obese) and utilizing
this entry site will also reduce harvest time. [0052] Cost--the procedure
described herein will be considerably less expensive than the
conventional procedure because described invention requires no operating
room time, reduced support personnel, and no anesthesiologist. In terms
of peripheral blood hematopoietic stem cell aspiration via apheresis--the
$6,000410,000 cost for GCSF cytokine treatments and several lengthy
(4-20+ hours each) apheresis procedures will be negated. [0053]
Convenience: There is no significant lead or preparative time required to
perform a bone marrow harvest, as the procedure can be performed without
an operating room, or general anesthesia by a single operator. Critically
ill, or bone marrow donors who could not readily tolerate traditional
harvest methods would benefit. Marrow and or stem cells derived from
marrow could be obtained rapidly for use in follow-on therapeutic
interventions.

Qualities & Benefits:

[0054] This device and method could be applied to a range of soft tissue
extractions. Specific uses include, but are not limited to, the
aspiration of bone marrow, removal of fat, aspiration of blood and
muscle. We consider the bone marrow harvest application further for the
sake of illustration. [0055] To provide a bone marrow aspiration device
for the rapid extraction of small or large volumes of bone marrow from
the ileac, femur or other marrow containing bone marrow cavities or
spaces. [0056] To aspirate tissue such as marrow through a single skin
and bone puncture site into the marrow cavity. [0057] The ability to
control directionality of described invention within the marrow cavity
such that it can access majority of bone marrow space through a single
point of entry. [0058] To provide controlled aspiration suction through
described invention of bone marrow or other aspiratable substance such as
fat. [0059] Described invention will significantly shorten bone marrow
harvest time, not require general anesthesia, and result in cost
reductions compared to traditional bone marrow harvest of peripheral
blood stem cell collection. [0060] To enable access to multiple
diagnostic samples of bone marrow from disparate sites within the marrow
cavity

[0061] FIG. 1 is a diagram illustrating a device 100 for rapid aspiration
and collection of body tissue from within an enclosed body space
(hereinafter referred to as "aspiration device"), according to one
embodiment of the present invention. Aspiration cannula 105 couples to
optional handle 102 for ease of holding and operation.

[0062]FIG. 2 illustrates entry cannula 101 with core element 104,
according to one embodiment of the present invention. Entry cannula 101
comprises a needle with hollow central lumen accommodating a core element
104 for initial insertion into a bone marrow cavity or body tissue, for
example through the anterior ileac crest, posterior ileac crest, lateral
trocanter of the femur, or other location for aspiration bone marrow or
other body tissue. Aspiration cannula 105 enters the body tissue through
the entry provided by entry cannula 101.

[0063] Core element 104 comprises a trocar or other element for breaking
or piercing through the bone wall (or other tissue boundary) and creating
an entry for subsequent aspiration. Optionally, entry cannula 101 is
strong enough to break or pierce through the bone wall without the help
of core element 104.

[0064] In an alternative embodiment, an entry in the bone wall is created
using a tool other than entry cannula 101 and/or core element 104, such
as a separate trocar or other sharp tool for breaking or piercing the
bone wall, preparing the bone (or other tissue area) for the entry of
aspiration cannula 105.

[0065] Once an entry is created into the bone marrow and entry cannula 101
enters the bone marrow (or other body tissue intended for aspiration),
core element 104 is removed, leaving a hollow entry lumen with access to
the medullary cavity.

[0066] FIG. 3 illustrates aspiration cannula 105, according to an
embodiment of the present invention. Aspiration device 100 comprises
aspiration cannula 105, for entering through the hollow entry cannula 101
and through the bone wall (or other tissue area) entry into the marrow
space. Aspiration cannula 105 comprises flexible material allowing for
curvature for following bone marrow cavity (or other tissue area). In one
embodiment, aspiration cannula 105 has a length of 6-16 inches. The size
of the aspiration cannula 105 may vary based on the size and anatomy of
the patient and/or the bone marrow cavity (or other body tissue area)
intended for harvest.

[0068] Optionally, aspiration cannula 105 is steerable and directable.
FIG. 4a shows aspiration cannula 105 equipped with one or more steering
wires 107, according to an embodiment of the present invention.
Contraction or pulling of a steering wire 107 by operator results in
curvature of aspiration cannula 105 according to the direction and/or
location of contracted or pulled steering wire 107. Optionally, and as
shown in FIG. 4b aspiration cannula 105 comprises flexible material
and/or perforations 108 on the wall of aspiration cannula 105 allowing
for curvature and increased lateral flexibility, and/or oval
cross-section for limiting axes of curvature. Optionally, aspiration
cannula 105 comprises material with shape-memory, for example a shape
memory alloy (such as Nitinol), a shape memory plastic, or other metallic
or non-metallic material with shape-memory, for example resulting in a
curved profile of aspiration cannula 105, for providing directionality to
aspiration cannula 105 upon aspiration cannula's 105 entry into the body
tissue or body cavity.

[0069] Optionally, as shown in FIG. 4c, aspiration cannula 105 comprises a
universal joint 109 for providing a pivot point, allowing the contraction
or pulling of steering wires 107 to result in steering and/or change of
direction of aspiration cannula 105.

[0070] Optionally, as shown in FIG. 4d, aspiration cannula 105 comprises a
squash plate 110, allowing the contraction or pulling of steering wires
107 to result in steering and/or change of direction of aspiration
cannula 105.

[0071] Optionally, as shown in FIG. 4e, aspiration cannula 105 a preset
degree of curvature such that after passing through entry cannula 101 and
into the bone cavity, aspiration cannula 105 assumes a curvature
according to the preset curvature, thereby assisting its direction when
advancing within the cavity.

[0072] Optionally and as illustrated in FIG. 5, a groove cup 120 is used
for guiding aspiration cannula 105 into bone marrow (or other body
tissue). Groove cup 120 comprises one or more grooves 121, a groove 121
providing directional entry of aspiration cannula 105 into bone marrow.
Placement of aspiration cannula 105 into an appropriate groove 121 allows
entry of aspiration cannula 105 into bone marrow with directionality
according to selected groove 121. Optionally, groove cup 120 has groove
dial 122 for convenient selection of groove 121 and guiding of aspiration
cannula 105 through selected groove 121 and into the bone marrow space.

[0073] According to one embodiment of present invention and as shown in
FIG. 6a, aspiration device 100 comprises a distal tip 130 at the distal
end of aspiration cannula 105 or at the distal end of optional aspiration
stylet 106, for advancing through the bone marrow cavity (or other body
tissue).

[0074] As shown in FIG. 6b, Distal tip 130 comprises a sharp tip 131, a
rotating drill tip 132 (manual or powered, for example powered by an
electric motor 162 as shown in FIG. 9, with motor 106 using power from
batteries 163 or from an outside electrical source), optionally
comprising a variable speed controllable and/or reversible drill tip), a
sonication device 133 (for tissue disruption) or other tissue disruptor
for penetrating and/or advancing through the bone marrow (or other body
tissue).

[0076] Optionally, distal tip 130 is modified such that it cannot puncture
out of the body space or cavity (such as bone marrow space or other body
tissue area) but instead moves sideways along a wall or boundary upon
encountering such wall or boundary. FIG. 6d shows an example of a distal
tip 130 modified to have a rounded blunt tip 135 to behave in this way.

[0077] Optionally, aspiration device 100 comprises a combination of
radio-opaque and/or radio-transparent material for use in conjunction
with an imaging device, such as an X-ray or ultrasound device, for visual
location of the aspiration cannula 105. For example, aspiration cannula
105 and/or other parts may be radio-transparent, with aspiration cannula
105 comprising a radio-opaque visual guide (for example using X-Rays or
other radiographic methods) along the length of aspiration cannula 105
(such as a strip with visual distance markings showing how far aspiration
cannula 105 has advanced into bone marrow space or other body tissue
area).

[0078] As shown in FIG. 7 according to one embodiment of the present
invention, aspiration cannula 105 comprises one or more inlet openings
150 near the distal tip 130 through which marrow or other tissues can be
aspirated by the application of negative pressure. A negative pressure
element couples to the proximal end of aspiration cannula 105 for
application of negative pressure resulting in aspiration (suction) of
bone marrow (or other body tissue) into a reservoir for bone marrow (or
for other body tissue). In one embodiment, the negative pressure element
comprises a syringe. In another embodiment, the negative pressure element
comprises a powered device (such as a wall mounted continuous negative
pressure device or other powered device for providing controlled negative
pressure). Handle 102 has optional trigger element 103 (as shown in FIG.
9) for controlling aspiration negative pressure or degree of suction, for
example by controlling a pressure gate for allowing proper degree of
negative pressure.

[0079] Optionally, aspiration device 100 comprises a pain attenuating
device for dampening pain and/or sensation during the aspiration
procedure. For example, aspiration cannula 105 may comprise one or more
sites for providing electrical nerve stimulation to the harvest area
resulting in pain attenuation (see U.S. Pat. No. 6,159,163, Strauss et
al., May 1998).

[0081] Optionally and as shown in FIG. 8, aspiration cannula 105 has one
or more additional ports 160 through which material or liquid (such as
anticoagulant described above) can be administered. An optional port in
the aspiration cannula 105 allows administration of a stylet into the
aspiration cannula for unblocking or removing any blood or tissue clots
which may occur. Aspiration device 100 comprises optional reservoir 161
for materials or liquids (such as anticoagulant described above) for
administration, as shown in FIG. 9.

[0082]FIG. 9 also shows an example of a steering control 140 for
steering, guiding, advancing, and/or retracting aspiration cannula 105
while aspiration cannula 105 in outside and/or inside bone marrow space
(or other body tissue area). In the embodiment described above, wherein
aspiration cannula 105 comprises one or more steering wires 107,
activation of steering control 140 causes contraction or pulling of one
or more steering wires 107 resulting in curvature and/or change of
direction of aspiration cannula 105. In one embodiment, steering control
140 comprises a manual control, such as a handle, which can be moved to
steer or manipulate aspiration cannula 104. For example, forward movement
of apparatus 100 causes advancement of aspiration cannula 105 and
backward movement of apparatus 100 results in withdrawal of aspiration
cannula 105, whereas movement of steering control 140 handle to different
sides (for example to the left, right, up or down) causes aspiration
cannula 105 to curve to the corresponding side (for example to the left,
right, up or down). In another embodiment, steering control 140 comprises
a powered control, such as a multi-way thumb-stick or one or more buttons
for steering and/or advancing and retracting aspiration cannula 105
(shown in FIG. 9).

[0083] The length and/or diameter and/or flexibility and/or curvature of
entry cannula 101 and/or aspiration cannula 105 can be chosen to
accommodate different anatomies (such as corresponding to different ages,
bone sizes, amount of body fat, and other factors distinguishing
patients) and for the harvest of a range of body tissues, such as bone
marrow, fat (liposuction), fluid in the abdomen of a patient (with liver
disease for example), or possibly for minimally invasive removal of a
soft tissue mass such as a tumor. For example, a child may require a
shorter, more flexible aspiration cannula 105. As another example,
aspiration of bone through the lateral trocanter of the femur, or via the
anterior ileac crest may require a shorter entry cannula 101 and/or
aspiration cannula 105 than aspiration of bone marrow through the
posterior ileac crest which may have more soft tissue above the bone.

[0084] There is growing body of scientific evidence that bone marrow
derived stem cells can be utilized to regenerate or improve function of
damaged myocardium following a myocardial infarction (MI), and may be
useful in treating and preventing congestive heart failure. The ability
to rapidly and easily obtain bone marrow derived stem cells for use in
cardiac regeneration and other regenerative stem cell based therapies may
be crucial. For example; a patient who has recently been diagnosed with a
significant myocardial infarction is brought to the catheterization
suite, where interventional cardiologists perform angioplasty to open up
a blocked coronary artery. Before, during or after the angioplasty
procedure, a significant volume of bone marrow would be harvested using
aspiration device 100. The bone marrow could be rapidly processed to
enrich for hematopoietic stem cells or other populations or fraction of
cells contained within bone marrow. These cells would then be delivered
via catheter of other delivery device to the region of the heart which
has undergone infarction and injury or death secondary to acute cardiac
ischemia or other acute or chronic insults to the myocardial tissue. The
delivered bone marrow or stem cell component contributes to regeneration
of the myocardium or otherwise acts to improve cardiac function in the
area of the infarct and leads to improved cardiac function and patient
functional status and mortality. Optionally, marrow could be harvested
separately from the initial cardiac catheterization procedure (for
example 7 days after the MI, and in a separate procedure, stem cells or
marrow enriched for stem cells could he delivered by any number of
delivery mechanisms, for example by intracoronary or intramuscular
injection. Use of a minimally invasive harvest device 100 would
facilitate ease of harvest in patients who may be critically ill and not
able to easily tolerate traditional marrow harvest procedures.

[0085] Advantageously, aspiration device 100 considerably improves on
existing bone marrow harvest procedures by enabling a single operator to
harvest marrow through one bone entry point, as illustrated in FIG. 10a,
instead of several dozen to hundreds of bone punctures and separate small
volume aspirations, as shown in FIG. 10b.

[0086] FIG. 11 illustrates a method for rapid aspiration and collection of
body tissue from within an enclosed body space, according to an
embodiment of the present invention. After providing 200 an entry into
the marrow using entry cannula 101 (and/or using core element 104, in
which case the core element 104 of the entry cannula 101 is removed after
providing the entry), a hollow entry lumen is left with access to the
medullary cavity. Next, aspiration cannula 105 is placed 201 through the
hollow entry cannula 101 and introduced into the marrow space. The
aspiration cannula 105 is then manipulated 202 (using steering control
140) to move and follow the bone marrow cavity, assisted by the distal
tip 130 the aspiration cannula.

[0087] As described above, aspiration cannula 105 will have a degree of
flexibility and/or curvature allowing it to follow the cavity (for
example the intramedullary bone marrow space of the ileac or femur bone),
and an optional ultrasound transducer device at the distal tip 130 of the
aspiration cannula 105 can aid movement and define width of the cavity.

[0088] Once the aspiration catheter is fully introduced into the body
cavity, negative pressure is initiated 203, using for example a syringe
or a powered negative pressure device as described above. As bone marrow
is aspirated the aspiration cannula 105 is slowly withdrawn 204, with
aspiration continuing as the aspiration cannula 105 is withdrawn. If 205
sufficient amount of bone marrow is aspirated 205, the aspiration process
is complete 206. Otherwise 207, after withdrawal of aspiration cannula
105, the curvature and/or directionality of the aspiration cannula 105 is
adjusted 208, and aspiration cannula 105 is redirected through the entry
into the bone marrow space and manipulated to follow a different path
through the space and aspirating more bone marrow. This process can be
repeated for example 3-4 times, resulting in its aspiration of bone
marrow from the majority of the bore marrow space (for example the ileac
crest). This process can be repeated 011 both sides of the body as needed
(FIG. 12 shows an entry site on one side of the body with multiple
aspiration paths).

[0089] As described above, there is the option of utilizing one or more
aspiration cannulae 105 with preset or modifiable degrees of curvature
and/or length and/or diameter and/or flexibility to adapt to different
individual patients' anatomy and degree of ileac or other bone anatomy.
As described above, aspirated bone marrow will go directly into bone
marrow reservoir or container through a closed system for initial storage
and/or follow-on manipulation (such as filtering, stem cell enrichment,
or other follow-on manipulation or treatment of bone marrow).

[0090] The apparatus and method shown herein provide many advantages for
rapid aspiration and collection of body tissue from within an enclosed
space. The directional control of the aspiration cannula by the operator
enables the cannula to directly contact more of the marrow space and
thereby aspirate a bone marrow that is more concentrated with stem cells
than that available in the prior art. In addition, the harvest performed
with the apparatus shown herein proceeds faster than prior art harvesting
with a trocar since only one access point is required on each side of the
body and less total volume of material is extracted. Finally, the
procedure outlined above requires less time and reduced support
personnel, thereby reducing costs for a procedure for harvesting bone
marrow and/or tissue.

[0091] Foregoing described embodiments of the invention are provided as
illustrations and descriptions. They are not intended to limit the
invention to precise form described. Other variations and embodiments are
possible in light of above teachings, and it is thus intended that the
scope of invention not be limited by this Detailed Description, but
rather by Claims following.